Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2002/047—Urethrae
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
  • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

• the device or prosthesis in accordance with the present invention solves the problem of therapy and prevention of repetitive strictures of man's urethra.
• Urethral stricture is when the urethra, the tube that leads from the bladder out of the body, is scarred by an infection or injury and narrows, eventually reducing or blocking the flow of urine from the bladder. Since males have a substantially longer urethra than females, urethra stricture is common in men, but rare in women. Urethral stricture can vary depending on the cause of scarring and length of the scar.
• Urethral stricture may be caused by inflammation or scar tissue from surgery, disease, or injury. It may also be caused by external pressure from an enlarging tumor near the urethra, although this is rare. Increased risk is associated with men who have a history of sexually transmitted disease (STD), repeated episodes of urethritis or benign prostatic hyperplasia (BPH). There is also increased risk of urethral stricture after an injury or trauma to the pelvic region. Any instrument inserted into the urethra (such as a catheter or cystoscope) increases the chance of developing urethral strictures. Urethral stricture may totally block urine flow, causing acute urinary retention, a condition that must be alleviated rapidly. Satisfactory treatment, i.e.
• urethral stricture is very dreaded and therapeutically difficult situation which can any surgeon hardly avoid.
• Today main therapeutic approaches are briefly described hereafter. Placement of a suprapubic catheter, which allows the bladder to drain through the abdomen, may be necessary to alleviate acute problems such as urinary retention. Dilatation of the urethra may be attempted by inserting a thin instrument to stretch the urethra under local anaesthesia. If urethral dilation is not possible, surgery may be necessary to correct the condition. Surgical options vary depending on the location and the length of the stricture.
• Cystoscopic visual urethrotomy may be all that is needed for small stricture.
• a urethral stent for cystoscopic insertion may also be used.
• An open urethroplasty may be performed for longer stricture by removing the diseased portion or replacing it with other tissue.
• the results vary depending on the size and location of urethroplasty, the number of prior therapies, and the experience of the surgeon.
• the invention relates to a resorbable device or prosthesis for use in prevention and/or treatment of urethral stricture.
• the device of the invention is intended to first, once inserted, maintain urethral diameter at the desired size and secondly reinforce, while the prosthesis resorbs according to control kinetics, the urethral wall and prevent stricture occurrence by enhancement of fibrotic tissue along the external device surface.
• This dual function of the device of the invention is allowed by the adapted shape of the prosthesis and by the used material. Both are necessary for a successful usage of the device.
• the shape of the device is intended to independently allow the longitudinal flow of urine and the radial mucous drainage while maintaining the prosthesis at the desired location by a simple sutureless wall adhesion.
• the used material is engineered in a biocompatible resorbable synthetic or natural polymer with adapted mechanical and chemical properties to get the desired rigidity, resistance and friction and to concurrently bio-absorbs while promoting fibrotic tissue formation that will act a comparative role once the prosthesis would have fully resorbed.
• the device or prosthesis of the invention mainly consists in a tube made in a polydioxanone polymer sized at the desired dimensions (inner and outer diameters, cone angle, and length) with a specific treatment of the external surface creating roughness and a net of small radial orifices with slightly arising margins.
• the resorbable intra-urethral prosthesis according to the invention distinguishes itself by the characteristics given in claim 1 and different embodiments are defined according to the dependant claims.
• FIG. 1 is a schematic view of a first embodiment of the prosthesis.
• Figure 2 is a detailed view of the surface of the prosthesis.
• Figure 3 is a schematic view of a second embodiments of the prosthesis
• BIORING SA has patented her annuloplasty prosthesis for use in remodelling a diseased annulus of a natural heart valve described in the document EP 1.284.688.
• the approach has to be different as far as it shall allow fluid circulation inside the prosthesis but prevent its occlusion by internal cells development.
• material engineering cannot be directly derived from annuloplasty prosthesis as far as the resulting mechanical and chemical characteristics are to be different as a consequence of applied forces and nature of contact medium (presence of urine leads to accelerated kinetics for resorption process).
• the basic idea is the construction of the device in accordance with the invention is to implant, after the cutting through the stricture, a stent from biocompatible resorbable material, which would during temporary time depending on the construction and composition of stent guarantee the complete healing with sufficient size of urethra and prevented the stricture due to the scaring by a fibrous tissue.
• controllable capacity of resorption of used material is the key to the special construction which on one side permits the drainage of natural secretion of a healthy mucous membrane and on the other side by its character prevents ejection of the stent by urine flow.
• Bio-absorbable (or resorbable) materials known to be useful in healthcare industry are either obtained from tissues or proteins coming from animal sources (e.g. collagen or catgut) or yielded by synthetic polymers.
• the main polymers known to be bio-absorbable include polyesters, polyorthoesters, polyanhydrides, poly(ether)esters, polyaminoacids and polydepsipeptides.
• bio-absorbable polymers often, but not only, bear the general pattern:
• X1 ; X2 are an oxygen atom or a NH group
• - Y1 (resp. Y2) is an oxygen atom or a NH group or a chemical bond between R1 and R3 (resp. R2 and R4)
• R1 ; R2 ; R3 ; R4 are linear or branched, saturated or not, bearing heteroatoms or not, carbon skeletons with (0 or 1) to 10 carbon atoms.
• X1 ; X2 are an oxygen atom
• Y1 is an oxygen atom or a chemical bond between R1 and R3 (resp. R2 and R4),
• R1 ; R2 ; R3 ; R4 are linear or branched carbon skeletons with (O or 1) to 3 carbon atoms.
• polymers include polyglycolydes, polydioxanones, polylactones, polylactides, and polyalkylenecarbonates. To these homopolymers can be added those obtained by copolymerisation of starting monomers. These polymers are convenient because they are in vivo absorbed according to known processes.
• polydioxanones and more precisely poly-1 ,4-dioxanones, were selected because of the absorption kinetics. They are known to be bio-absorbed slower than polylactides or polyglycolides or even than collagen or catgut. Besides, if the properties of the poly-1 ,4-dioxanone are suitably adjusted, the material can have softness and rigidity parameters convenient for the application.
• polydioxanones are today widely used in surgery. Proofs of polydioxanone bio- compatibility and innocuousness have already been widely evidenced.
• the chosen resorbable material can be dyed be a bio-compatible pigment to improve visibility and even coated (in a bio-reversible manner) by various compounds like siliconized solution, diamond- or pyrolytic carbon or echogenic (contrast) solution or antiseptic solution.
• the construction of the device is schematically depicted on figure 1.
• the device of the present invention can be represented as a tube 1 characterized by dimensional parameters:
• the device of the invention is then cylindrical (or tubular).
• the device of the invention is then cylindro-conic, having tubular frusto-conical shape.
• the wall thickness "e”, as previously defined, can be constant over the all device length or can vary between extremes “e m i n " and "e Max ".
• e the wall thickness of the wall thickness "e”
• e Ma ⁇ the wall thickness of the wall thickness "e”
• Figure 2 provides with a detail view of the surface of the device.
• the surface is characterized by the presence of orifices 2 permitting drainage of mucous membrane. They are characterized by their internal diameter "z” and their density "n” as a number of orifices by surface units (i.e.100 mm 2 ).
• base parameter is a parameter that cannot be deduce from another base parameter by any of provided equation
• FIG. 1 shows a second embodiment of the device with a split.

Priority Applications (7)

Applications Claiming Priority (1)

Publications (2)

Family

ID=37909198

Family Applications (1)

Country Status (7)

Cited By (3)

Citations (5)

Family Cites Families (28)

• 2006
  • 2006-11-06 JP JP2009535139A patent/JP2010508878A/ja not_active Abandoned
  • 2006-11-06 WO PCT/IB2006/003117 patent/WO2008056194A1/en active Application Filing
  • 2006-11-06 US US12/513,405 patent/US8486154B2/en not_active Expired - Fee Related
  • 2006-11-06 AU AU2006350695A patent/AU2006350695B2/en not_active Ceased
  • 2006-11-06 RU RU2009121671/14A patent/RU2009121671A/ru unknown
  • 2006-11-06 EP EP06820851A patent/EP2086463A1/en not_active Withdrawn
  • 2006-11-06 CA CA002668481A patent/CA2668481A1/en not_active Abandoned

Patent Citations (6)

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